Therapeutic Intra-vaginal Devices &amp; Methods

ABSTRACT

Intra-vaginal devices and methods are disclosed for a broad range of applications in the women&#39;s health field. The devices and methods provide for placement in the cervical region, and for transferring heat to a cervical region, a barrier contraception method, collection of menstrual fluid, and release of drugs and/or hormones intra-vaginally. The device also can address multiple women&#39;s health issues.

RELATED APPLICATIONS

This application: claims priority under 35 U.S.C. §119(e) to U.S. patentapplication Ser. No. 60/864,506, filed on Nov. 6, 2006, entitled “Deviceand Method for Amelioration of Dysmenorrhea,” which is incorporatedherein in its entirety by reference.

BACKGROUND

The present invention relates to intra-vaginal devices, and morespecifically, to intra-vaginal devices and methods for providingtherapeutic treatment to the cervical region.

Women's personal health products, including feminine hygiene products,reproductive health products, and other women's health products, haveseen relatively little progress in the past fifty years. Women lookingfor solutions to today's myriad feminine health issues traditionallyhave turned to the same antiquated devices and techniques as generationsbefore them.

For relief from dysmenorrhea, for example, women typically turn toeither chemical means, i.e., pain relief medications, hormones, orapplication of external heat to the pelvic region. These relief optionstend to provide inadequate effectiveness, and are associated with otherdisadvantages such as the visibility of external heat application andthe side effects and limitations of hormones and pain relief drugs toprovide consistent pain relief for the duration of a woman's menstrualcycle.

For various other women's health issues in which an intra-vaginal devicemay be used, such as barrier methods of birth control (e.g., diaphragm,cervical cap), insertable chemical contraceptive devices, as well asnewer methods of collection of menstrual fluid (e.g., disposablemenstrual cups), manual insertion and removal remain the norm. Manywomen find such manual techniques complicated and unhygienic. Of these,the barrier birth control devices often have additional shortcomingsassociated with them, such as need for a precise fit and thus medicaloffice fittings for devices made in a variety of sizes. Alternatives todisposable menstrual cups remain limited to tampons and sanitarynapkins, products that are often inconvenient, limited to short periodsof wear, and/or associated with additional health risks, such as ToxicShock Syndrome.

SUMMARY

In various embodiments, the present invention provides intra-vaginaldevices, as well as methods for use and insertion thereof, with a broadrange of applications in the women's health field.

In one embodiment, the present invention provides an intra-vaginaldevice capable of transferring heat to a cervical region and a methodfor using the same. The heat thereby transferred is therapeutic, e.g.,the heat aids in amelioration of menstrual cramps or othercervical-vaginal discomfort. Uterine cramping is believed to be causedby contraction of the uterine muscles and/or dilation of the cervix, andthus heat applied to the cervical area will have the effect of relaxingthe tissues, increasing perfusion, and facilitating dilation. Thisembodiment of the device of the present invention can take variousshapes as described herein. The placement of the device in the cervicalregion provides direct heat transfer to the cervix uteri and surroundingtissues, providing effective pain relief. In addition, because thedevice can remain in place for an extended period of time, the deviceallows for little-to-no interruption in pain relief during a woman'smenses. Use of the device is not visible to the outside observer andprevents the need for multiple doses, e.g., of pain-relief drugs orhormone therapies.

In another embodiment, the present invention provides a collapsibleintra-vaginal device and insertion method for placement adjacent to acervix uteri for various women's health applications. The device in thisembodiment can be used by women with a range of cervix uteri sizes, andthe device and method provide for self-alignment during insertion forcorrect placement adjacent to the cervix uteri. This embodiment of thedevice can be used with therapeutic heat as discussed for the aboveembodiment, as a barrier birth control method (with or withoutspermicide), for collection of menstrual fluid, and for release of drugsand/or hormones intra-vaginally, as well as for other applications forwhich proximity to the cervix uteri is important.

In addition to avoiding many of the above-referenced shortcomings of thevarious prior devices and methods, the present invention allows theability to address multiple women's health issues with a single device.

The description in the specification is not all inclusive and, inparticular, many additional features will be apparent to one of ordinaryskill in the art in view of the drawings, specification, and claims.Moreover, it should be noted that the language used in the specificationhas been principally selected for readability and instructionalpurposes, and may not have been selected to delineate or circumscribethe inventive subject matter.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A and 1B show cross-sectional side and front line drawing views,respectively, of the female reproductive anatomy.

FIGS. 2A, 2B, and 2C are perspective, top view, and cut-away side viewsof an intra-vaginal device according to one embodiment of the presentinvention.

FIG. 3A & 3B are perspective view and cut-away side views of atampon-based intra-vaginal device according to one embodiment of thepresent invention.

FIGS. 4A & 4B are perspective and cut-away side views of anintra-vaginal device in an expanded configuration according to oneembodiment of the present invention.

FIGS. 4C & 4D are side and top views of an intra-vaginal device in acollapsed configuration according to one embodiment of the presentinvention.

FIGS. 4E & 4F are cut-away side and top views of an intra-vaginal devicein a webbed expanded configuration according to one embodiment of thepresent invention.

FIG. 4G is a top view of an intra-vaginal device in a webbed collapsedconfiguration according to one embodiment of the present invention.

FIGS. 5A & 5B are perspective and side views of a C-shaped intra-vaginaldevice according to one embodiment of the present invention.

FIG. 6 is a perspective view of a ring-shaped intra-vaginal deviceaccording to one embodiment of the present invention.

FIGS. 7A and 7B are cut away side views of a gelatinous ballintra-vaginal device according to one embodiment of the presentinvention.

FIGS. 8A-8C are cross-sectional views of three embodiments of insertedintra-vaginal devices according to the present invention.

FIG. 9 is a perspective view of an intra-vaginal device in conjunctionwith a heating apparatus according to one embodiment of the presentinvention.

FIGS. 10A-10E are cut-away side views of intra-vaginal devices withvarious heating elements according to various embodiments of the presentinvention.

FIG. 11 is a perspective view of an intra-vaginal device with aninternal battery pack according to one embodiment of the presentinvention.

FIG. 12 is a perspective view of an insertion device in conjunction withan intra-vaginal device according to one embodiment of the presentinvention.

FIG. 13 is a cut-away side view of an intra-vaginal device enclosed inan insertion device according to one embodiment of the presentinvention.

FIGS. 13A-13B are cut-away side views of insertion of an intra-vaginaldevice via an insertion device according to one embodiment of thepresent invention.

FIGS. 13C-13D are side views of insertion of an intra-vaginal device viaan insertion device according to one embodiment of the presentinvention.

FIG. 13E is a side view of removal of an insertion device according toone embodiment of the present invention.

One skilled in the art will readily recognize from the followingdiscussion that alternative embodiments of the structures and methodsillustrated herein may be employed without departing from the principlesof the present invention.

DETAILED DESCRIPTION OF THE EMBODIMENTS Definitions

The term “adjacent,” as used herein is used in it's traditional usage,meaning nearby or close to; proximate. Items that are adjacent may ormay not be contiguous (touching).

The term “cervical region,” as used herein includes the upper portion ofthe vagina and the lower portion of the uterus. The “upper portion,”according to various embodiments, may be the portion about the midpointof the vagina, the upper two-thirds (⅓) of the vagina, or within twoinches of the cervix. In one embodiment, the cervical region comprisesthe tissues immediately surrounding the cervix uteri.

The term “dysmenorrhea,” as used herein is defined as pain or discomfortexperienced just before or during a menstrual period.

The term “frustum,” as used herein is defined as the portion of asolid—normally a cone or pyramid—which lies between two parallel planescutting the solid; aach plane section is a base of the frustum.

The term “perfusion,” as used here, means fluid flow through an organ ortissue.

The term “therapy,” as used herein refers to any useful alterationassociated with feminine health, and as used herein includes, but is notlimited to, heat therapy, chemical therapy, hormone therapy, birthcontrol, and retention of menstrual fluid.

“Therapeutic heat,” as used herein, is heat therapy. In one embodiment,therapeutic heat provides for amelioration of discomfort of the cervicalregion. In one embodiment, the range of heat that is therapeutic isbetween 97.0 and 120.0 degrees Fahrenheit. Therapeutic heat, in anotherembodiment, is the amount of heat transfer required to change thetemperature of the cervical region tissues. The heat means may be ofvarious forms, including but not limited to, electric, fluid flow,exothermic chemical reaction, passive, or thermonuclear.

Anatomical Context

FIGS. 1A and 1B show cross-sectional side and front line drawing views,respectively, of the female reproductive anatomy. As depicted, theportion of the cervix 105 that protrudes into the vagina 107 is theportio vaginalis 110, or ectocervix. The uterus 111 defines fundus 113,which terminates in cervical os 115. The vaginal walls 117 and portiovaginalis 110 define the fornices vaginae, or vaginal fornices 119. Asused herein, the cervical region comprises the cervix 105 itself and thesurrounding tissues of the uterus 111 and vagina 107. The term cervical,as used herein, refers to aspects of the female anatomy in the cervicalregion.

The cervix 105 may present itself in various positions with respect tothe vaginal canal 107. It is rarely directly aligned with the axis ofthe vaginal canal 107. As shown in FIG. 1A, e.g., the cervix 105 oftenis aligned at a slight angle from the axis of the vaginal canal 107 withrespect to the vaginal opening 120. The size of the cervix 105 andvagina 107 also may vary greatly from one woman to another. Theabove-described anatomy thus provides a frame of reference for thedevices and methods described herein.

Device Architecture

In various embodiments, the present invention provides intra-vaginaldevices, as well as methods for use and insertion thereof, with a broadrange of applications in the women's health field. FIGS. 2A, 2B, and 2Care perspective, top, and cut-away side views of an intra-vaginal deviceaccording to one embodiment of the present invention.

Referring to FIG. 2A, it shows a perspective view of an intra-vaginaldevice 205 according to one embodiment of the present invention. Theembodiment of the device 205 shown in FIGS. 2A-2C is a short, flared,cylindrical ring or hollow inverted conical frustum, however, the devicetakes other shapes according to various embodiments. The device 205 isdesigned for placement in the cervical region. The flared cylindricaldevice 205 shown in FIG. 2A, for example, is of sufficient diameter andlength optimized for comfortably surrounding the portio vaginalis 110.The size of the portio vaginalis varies significantly from woman towoman, with the average size being 3 cm in diameter and 2.5 cm inlength. A woman's cervix 105 is approximately hemispherical in shape.Thus, the device 205 is shaped in a manner that approximately matchesthe shape of the cervix 105. The embodiment of the device 205 shown inFIGS. 2A-2C has an open bottom, however, the device 205 bottom may beclosed, or solid, in some applications.

Thus, the device 205 in one embodiment comes in a plurality of sizes toaccommodate various anatomies, and is comprised of a pliable,elastomeric material so as to allow a relatively small number of sizesto fit a wide variety of women without excessive custom fitting. Inother embodiments, the device 205 is made of somewhat more rigidmaterials, as appropriate for the overall device configuration. Thechoice of materials, for example, may be determined so as to easeinsertion and/or removal of the device 205 in combination with comfortto the user and effectiveness of the intended therapeutic use. In oneembodiment, the materials are hypoallergenic. For example, the device205 may be made of silicone rubber, latex, polyurethane, and variousother materials suitable for this purpose. The device 205 is reusable orsingle-use according to various embodiments. As a result, the materialsused for the device 205 may be selected for durability or economy,respectively.

FIG. 2B shows a top view of the device 205 of FIG. 2A. In oneembodiment, the device 205 is used in conjunction with a heat source forproviding heat to the cervical region. The embodiment in FIGS. 2B and 2Cis a device 205 with an electrical heating element 210, depicted as athick dashed line in the interior of the device 205. A thin dashed line215 illustrates a cut through the plan view of the device 205; thecut-away side view is shown as FIG. 2C. The electrical heating element210 is visible in FIG. 2C, which shows a serpentine configuration of theheating element 210. In other embodiments, other heating element 210configurations are used, e.g., as described below in greater detail inconjunction with FIGS. 9-10E.

FIG. 3A & 3B are perspective view and cut-away side views of atampon-based intra-vaginal device 305 according to one embodiment of thepresent invention.

In one embodiment, the device is used in conjunction with a tampon, andis inserted in conjunction with insertion of a tampon by known methods.An example of a tampon-based device 305 is shown in FIG. 3A. In thisembodiment, the top portion of the tampon-based device 305, forplacement adjacent to the cervix 105, is similar to the flaredcylindrical device 205 described above. However, the tampon-based device310 additionally has a secondary ring structure 310 that attaches to astandard tampon 320. The secondary ring 315 is separated from the topportion 205 of the device 305 by support members 315 that provide a gapto allow for normal menstrual flow to reach the tampon 320. Removal ofthe device 310 is in conjunction with the normal removal of the tampon320 according to one embodiment. The tampon-based device 305 shown ismerely one configuration; other embodiments may take a number of otherconfigurations. The tampon-based device 305 may also provide heat asreferenced above and discussed in greater detail below. Thus, a heatingelement 210 is shown in FIG. 3B.

The device 205 shown above may also be used for other applicationsaccording to various embodiments, e.g., for menstrual fluid collection,chemical birth control, or barrier method birth control. Theseapplications are described in greater detail in conjunction with FIGS.4A-4G.

FIGS. 4A & 4B are perspective and cut-away side views of anintra-vaginal device 405 in an expanded configuration according to oneembodiment of the present invention. The device 405 is designed forplacement in the cervical region, adjacent to a cervix uteri 105. Thedevice 405 has an approximately circular, ring-shaped base 410 and twoor more flaps 415 attached at one end to the base 410 according to oneembodiment. The depicted device 405 has four (4) flaps 415, however, thedevice 405 may have more or less than four flaps 415. In the expandedconfiguration shown in FIGS. 4A and 4B, the flaps 415 togetherapproximate the shape of a hollow inverted frustum, or an open-bottombowl shape, in one embodiment, with the ring 410 forming the bottom,ring base and the end of the flaps 415 not connected to the ring 410forming the top base of the frustum. Thus, the device 405 is shaped in amanner that approximately matches the shape of the cervix 105. As shown,the flaps 415 can easily open or close to varying degrees to accommodatea variety of cervix 105 sizes. In some embodiments, the device 405 mayhave a string, or wire, 420 to aid in removal.

In the embodiment depicted, the area inside the ring 410 is hollow, andthus the device 405 is open. The hole in the ring-shaped base 410 issufficiently large to allow flow of menstrual and other vaginal fluidsto pass through. Slits 425 between the flaps 415 supply an additionalpathway for fluid flow.

FIGS. 4C & 4D are perspective and top views of an intra-vaginal device405 in a collapsed configuration according to one embodiment of thepresent invention. As shown, the flaps 415 can overlap each other in aspiraling fashion to attain a collapsed configuration. In thisembodiment, the flaps 415 are tapered towards the edges to facilitatethe successive nestling of one flap 415 under the edge of the adjacentflap 415. The overall circumference in the collapsed configuration issufficiently small to permit the device 405 to fit inside a cylindricaltube for insertion, as described in greater detail in conjunction withFIGS. 13A-13E. In addition, the shape of the upper portion of the device405 becomes tapered, which facilitates its exit from the cylindricaltube upon insertion. In the collapsed position, the flaps 415 ifunconstrained would have sufficient spring force as to tend to open upwhen the constraint is relieved.

FIGS. 4E & 4F are cut-away side and top views of an intra-vaginal device405 in a webbed expanded configuration according to one embodiment ofthe present invention, and FIG. 4G is a top view of an intra-vaginaldevice in a webbed collapsed configuration according to one embodimentof the present invention. The webbed configuration is similar to theconfiguration described in conjunction with FIGS. 4A-4D, except that theflaps have webbing 430 between them in place of the slits 425, and thearea inside the ring base 410 is closed 435, or solid, such that flaps415 of the device 405 form a continuous structure with no apertures.

Thus, this embodiment of the device 405, once in place, is intended toblock the flow of fluids in or out of the os 115 of the cervix 105. Forexample, the device 405 can act as a barrier to seminal fluid, therebybeing suitable as a contraceptive device, or can block, or capture andretain, the flow of menstrual fluids, thereby being an alternative tofeminine napkins or tampons for use during menses. The device 405 inthis configuration may have addition features for its intended purpose,such as a receptacle for collection of seminal or menstrual fluids, orretention of spermicide. The device 405 may include a string, tab, orother means for retrieval and removal.

According to the embodiment depicted in FIGS. 4A-4G, the device 405 ismanufactured out of materials that allow the device 405 to collapse andexpand as described above. In one embodiment, the webbing 430 is made ofan elastomeric material to allow to stretching of the diameter of thedevice 405, e.g., if the remainder of the device is not made of anelastomeric material. In another embodiment, the device 405 ismanufactured from an elastic, hypoallergenic material as discussed abovein conjunction with FIGS. 2A-2C. In these embodiments, the device 405can accommodate a variety of cervix sizes. The materials for the device405 should be sufficiently pliable so as to be collapsible, and suchthat they cause the device 405 to spring open, once inserted, to conformto the vaginal walls 117 without causing injury to those tissues.

FIGS. 5A & 5B are perspective and side views of a C-shaped intra-vaginaldevice 505 according to another embodiment of the present invention.

FIG. 6 is a perspective view of a ring-shaped intra-vaginal device 605according to one embodiment of the present invention. In thisembodiment, the device 605 may include an internal spring similar tothat commonly used in a diaphragm, and may be inserted and removed bysimilar methods.

FIGS. 7A and 7B are cut away side views of a gelatinous ballintra-vaginal device according to one embodiment of the presentinvention. In this embodiment, the device is comprised of a gelatinousball 705 or membrane that may take various shapes and sizes. Forexample, a gelatinous ball 705 may be affixed to a tampon 320 fordigital insertion, or may be used in conjunction with an insertiondevice 710 as shown. As shown, in one embodiment, when the ball 705 isinserted, it conformed to the interior of the cervical region. Thisdevice also may include a heating element. These embodiments are merelyexamples of various configurations the device can take; otherconfigurations are within the scope of the present invention.

FIGS. 8A-8C are cross-sectional views of three embodiments of insertedintra-vaginal devices according to the present invention. FIG. 8A showsplacement of a device 205 closely fitted over the hemispherical cervix105. Similarly, FIGS. 8B and 8C show placement of a device 405 webbed(FIG. 8C) or not (FIG. 8B) closely fitted over the cervix 105. Thedevices 205, 405 are placed into the cervical region. In someembodiments, the devices 205, 405 will touch the cervix 105, e.g., whena tight fit is necessary, such as when the device 205, 405 is used as abarrier-type contraceptive. In other embodiments, being within a maximumdistance from the cervix 105 is sufficient, e.g., for heat transfer tothe cervical and uterine tissues. In one embodiment, when the device205, 405 is in place, the hollow of the ring base 410 defines anaperture substantially in alignment with the os 115 of the cervix uteri105.

Therapy

The device 205, 405 described herein is configured for deliveringtherapy of various types to the cervical region.

One example of a use of the intra-vaginal devices 205, 405 describedherein is for providing therapeutic heat to the cervical region. Theexternal application of heat to the uterine/cervical area is awell-known method thought to reduce menstrual cramping. Menstrualcramping, or dysmenorrhea, has been a health challenge to women sincethe origin of the human species. Studies indicate that dysmenorrhea iscaused by uterine contractions and the dilation of the cervix 105 thatis required to allow menstrual discharge to pass through the opening. Acommon remedy for dysmenorrhea has been the application of heat to theabdomen by a variety of methods, e.g., electric heating pads, hot waterbottles, or warm baths. These therapies typically have provided limitedamelioration and have been supplanted by various drug therapies such asanalgesics, muscle relaxers, and various hormone therapies. However,some studies have maintained heat as a superior method of treatment.

The present invention allows heat to be delivered directly to the cervix105 and surrounding tissues. The device 205, 405 may receive heat byvarious means. In one embodiment, the device 205, 405 is passivelyheated. For example, the device 205, 405 may be heated by immersing thedevice 205, 405 in hot water of a specific temperature range to reachthe above-stated temperatures, or heated in a microwave, or by variousother heating methods. In this embodiment, the device 205, 405 hassufficient mass per unit volume and high specific heat to allownecessary storage of heat within the device 205, 405. Once sufficientlyheated, the device 205, 405 is inserted into position around the portiovaginalis 110, as described above, where its heat is given up to theadjacent tissues. In this embodiment, the device 205, 405 may bereusable, and thus may be reheated.

FIG. 9 is a perspective view of an intra-vaginal device 205, 405 inconjunction with a heating apparatus 905 according to one embodiment ofthe present invention. The heating apparatus 905 may be an electricheating means or a fluid flow device heating means according to variousembodiments. For example, the apparatus 905 may include wires 910 and abattery pack 915, or tubing 910 and a fluid flow device 915. In anelectrical heating embodiment, the device 205, 405 is connected to abattery pack 915 or other electricity source by wires 910. In oneembodiment, the device 205, 405 uses a pair of wires wrapped in a singlecovering 910. The wires 910 are of sufficient length such that thebattery pack 915 may be worn externally by the user, and such thatbattery replacement is possible without removal of the device. In someembodiments, the battery pack 915 may be accompanied by a variableresister or other current regulator (not shown) to more preciselycontrol, either automatically or manually, the temperature supplied tothe device 205, 405. Alternatively, the heat source 915 may operate thedevice 205, 405 via wireless transmission, e.g., via transcutaneousenergy transfer according to Faraday's principle.

Referring again to FIG. 9, in a fluid heating embodiment, a device 205,405 is connected to a fluid flow device 915 by tubing 910. The tubing910 is of sufficient length such that the fluid flow device 915 may beworn externally by the user. The fluid flow device 915 has thecapability of heating the fluid and pumping it around the fluid circuit.In some embodiments, the fluid flow device 915 may include one or moretemperature controls to more precisely control the temperature suppliedto the device 205, 405.

FIGS. 10A-10E are cut-away side views of intra-vaginal devices 205, 405with various heating elements 210 according to various embodiments ofthe present invention. The heating element 210 may take variousconfigurations, as shown in cut-away side views in FIGS. 10A-6E. FIG.10A illustrates a device 405 with an electrical heating element 210 in aserpentine pattern. This pattern allows the device 405 to stretch tosome degree to fit a particular individual. Referring briefly to FIGS.2B and 2C, another embodiment of the device 205 is shown with theheating element 210 in a serpentine pattern. FIG. 10B illustrates adevice 205 with an electrical heating element 210 in a helical array. Inthis embodiment, the heat may be supplied by as little as a single wirepositioned around the circumference of the device 205, for example, inan embodiment as depicted in FIG. 6. FIG. 10C illustrates a device 205with an electrical heating element 210 that is a film, e.g., made ofcarbon. FIG. 10D illustrates a device 205 with an electrical heatingelement 210 in a wire mesh pattern. These configurations are merelyexamples of various configurations the electric heating elements 210 cantake; other configurations are within the scope of the presentinvention.

The heating element 210 may include fluid heating. FIG. 10E illustratesa device 205 with a fluid heating element tube 210 in a serpentinepattern. Other configurations for fluid flow are possible, similar tothose described in conjunction with the electrical heating embodimentsshown in FIGS. 10A-10D. Although FIGS. 10A-10E show the heating element210 for only a single device 205, 405 configuration, these are merelyexamples. The various heating elements 210 can be configured in otherdevice 205, 405 shapes.

In another embodiment, the device 205, 405 is heated by an exothermicchemical reaction. In this example, materials encapsulated within thedevice 205, 405 allow for a chemical reaction that produces thenecessary heat.

In yet another embodiment, the device 205, 405 is heated by radiofrequency energy transfer. The list of heating methods described hereinis not exhaustive, and other technologies for transferring energy tohuman tissues to raise the temperature of the tissues are within thescope of the present invention.

For the above-described embodiments, the device 205, 405 also mayinclude a means for controlling the effective temperature range of thedevice, e.g., to ensure that the device temperature is kept in aspecific range for safety and effectiveness. For example, for passiveheat methods, the device 205, 405 may change colors corresponding tovarious temperatures. A thermocouple or other feedback device may beincorporated into the device 205, 405 in other embodiments, to provide areadout and facilitate sufficient temperature control. Any number ofcontrol technologies, including a failsafe circuit or chip, may be usedto provide greater control over the temperature of the device 205, 405.

The heat delivered to the cervix 105 must be warm enough to beeffective, but no so hot as to damage the cervical tissues. Thus, thedevice 205, 405 can operate at a wide range of temperatures. In oneembodiment, the device 205, 405 provides heat of a temperature range of97-120 degrees Fahrenheit. In another embodiment, the device 205, 405provides heat of a temperature range of 99-106 degrees Fahrenheit. Inyet another embodiment, the device 205, 405 provides heat of atemperature range of 100-104 degrees Fahrenheit. These ranges are notintended to be limiting; other temperature ranges are within the scopeof the present invention. In one embodiment, therapeutic heat providesfor amelioration of discomfort of the cervical region.

Referring again to FIGS. 3A and 3B, in the tampon-based device 305embodiment and in the internal battery pack embodiment 1100 described inconjunction with FIG. 11 below, electrical supply wires from the heatingelement 210 may continue down through the secondary ring 310, asdepicted in FIG. 3B. The heating element 210 then adjoins with thetampon 320 or battery pack 1105. In the tampon-based device 305, thewires 910 can be either external to the tampon 320 or can be leadthrough the tampon 320, exiting through the bottom where a retrievalstring typically is located.

FIG. 11 is a perspective view of an intra-vaginal device 1105 with aninternal battery pack according to one embodiment of the presentinvention. This embodiment of the device 1100 is similar to the tamponbased device 305, except that the device 1100 is attached to an internalbattery pack 1105 instead of a tampon, as shown in FIG. 11. Thisembodiment typically would be used when a tampon 320 is not be needed,e.g., for premenstrual cramping, or would be used in combination with anexternal sanitary napkin. This embodiment allows the device 1100 to beused without external wires 910 or battery pack 915.

Another example of a use of the intra-vaginal devices 205, 405 describedherein is for providing therapeutic chemicals to the cervical region.For example, the device 205, 405 is suitable for delivering variousdrugs and/or hormones to the cervical region by allowing the drugsand/or hormones to leach from the material from which the device ismolded. Thus, in one embodiment, the device 205, 405 comprises amaterial suitable for receiving and retaining a drug and/or hormone forintra-vaginal trans-tissue delivery.

Another example of a use of the intra-vaginal devices 205, 405 describedherein is to serve as a barrier type contraceptive device. Thus, thisembodiment of the device 405, once in place, is intended to blockseminal fluid from entering the os 115 of the cervix 105. The device 405in this configuration may have addition features, such as a receptacleor reservoir tip for collection of seminal fluid or retention ofspermicide.

Yet another example of a use of the intra-vaginal devices 205, 405described herein is to serve as a device for retention of menstrualfluid. Thus, this embodiment of the device 405, once in place, isintended to block the flow of menstrual fluids out of the cervix 105,e.g. by collecting and retaining the fluid.

Thus, the device 205, 405 and method described herein is configured fordelivering therapy of various types to the cervical region, wherein thetherapy may be heat therapy, chemical therapy, hormone therapy,contraception, and/or retention of menstrual fluid. In some embodiments,more than one type of therapy may be provided by the device 205, 405,for example heat therapy and retention of menstrual fluid by a device ina closed configuration that also has a heating element.

Insertion and Removal

According to some embodiments, the device 205, 305, 405, 1100 may beinserted digitally. In other embodiments, an insertion device may beused to aid insertion.

FIG. 12 is a perspective view of an insertion device 1205 in conjunctionwith an intra-vaginal device 205, 405 according to one embodiment of thepresent invention. In this example, the insertion device 1205 grasps theintra-vaginal device 205, 405 for insertion into the vaginal canal 107,and then releases the intra-vaginal device 205, 405, e.g., by way of alever on the insertion device 1205. FIGS. 8A-8C show inserted devices205, 405.

FIG. 13 is a cut-away side view of an intra-vaginal device 405 enclosedin an insertion device 1305 according to one embodiment of the presentinvention. The device 405 is shown in its collapsed configuration insidethe insertion device 1305. The ring-shaped base 410 and overlappingflaps 415 of the device 405 can be seen. The insertion device 1305includes a cylindrical outer tube 1310 with an insertion end 1311, abody 1313, and a grip end 1315, and a plunger 1320 with a device end1321, a body 1323, and a force receiving end 1325. The insertion device1305 is longer than, but similar in shape to a conventional tamponapplicator according to one embodiment. Although the insertion device1305 is shown with flaps at the insertion end 1311, the insertion device1305 may not have such flaps according to other embodiments. The plunger1320 is slideably received inside the cylindrical outer tube 1310, andthe device end 1321 of the plunger 1320 has an approximatelyhemispherical convex tip sized to nestle inside the ring base 410 of theintra-vaginal device 405. The plunger 1320 is designed such that as itexpels the device 405 from the tube 1310, it pushes against the centerring 410 of the device 405 and thus allows the device 405 to adjust itsangle relative to the plunger 1320 and the alignment of the cervix 105.Thus, the hemispherical tip allows for transfer of the force from theplunger 1320 to the device 405 such that the device 405 pivots intoalignment with the cervix uteri 105.

FIGS. 13A-13B are cut-away side views of insertion of an intra-vaginaldevice 405 via an insertion device 1305 according to one embodiment ofthe present invention; FIGS. 13C-13D are side views of insertion of anintra-vaginal device via an insertion device according to one embodimentof the present invention; and FIG. 13E is a side view of removal of aninsertion device according to one embodiment of the present invention.

Referring to FIG. 13A, the collapsed device 405 is shown within theinsertion device 1305. The plunger 1320 is positioned within the tube1310 and below the device 405, with the hemispherical tip 1321 of theplunger 1320 engaging the ring base 410 of the device. Because theplunger tip 1321 is larger in diameter than the base 410, it is unableto pass through the ring base 410, and thus can push the device 405 outof the cylindrical outer tube 1310.

FIG. 13A shows the insertion device 1305 having been introduced into thevaginal canal 107 with the intra-vaginal device 405 positioned in aconstrained configuration inside the cylindrical outer tube 1310 at theinsertion end 1311 of the tube 1310 proximate the device end 1321 of theplunger 1320, positioned for placement of the intra-vaginal device 405adjacent to the cervix uteri 105.

FIGS. 13B and 13C show the intra-vaginal device 405 being inserted bythe insertion device 1305. Upon application of force to the forcereceiving end 1325 of the plunger 1320, FIG. 13B shows the intra-vaginaldevice 405 being expelled out of the insertion end 1311 of thecylindrical outer tube 1310. FIG. 13C shows the device 405 having beenexpelled, expanding into an expanded configuration, causing the flaps415 to open until they touch the vaginal wall 117.

As the plunger 1320 pushes further with continued application of force,eventually one side of the device 405, i.e., one of the flaps 415,reaches the one of the fornices vaginae 119, as shown in FIG. 13C.Because the side of the device 405 touching a fornix 119 now isprevented from moving further, the axial force placed on the device 405creates a moment on the device 405, causing the device 405 to pivot, theforce being transferred along the hemispherical convex tip 1321 of theplunger 1320 such that the other side of the device 405 contacts afornix on the opposite side of the cervix 105, as shown in FIG. 13D.Thus, the insertion device 1305 naturally pivots the device 405 intocorrect alignment with the cervix 105 for its intended therapeuticeffect. Referring now to FIG. 13E, the insertion device 1305 is shownbeing removed, with the intra-vaginal device 405 left in place.

Removal of the device 205, 405 is by means of a retrieval string or tabaccording to one embodiment. In the embodiment in which the device 405has overlapping flaps 415, pulling the string moves the device 405 downthe vaginal canal 107, and the pressure exerted on the device 405 by thevaginal walls 117 causes the device 405 to change into the collapsedconfiguration. In the tampon-based configuration, pulling on the tamponstring 330 facilitates removal. In embodiments in which wires 910 ortubing 920 lead to the device 205, 405, pulling on the wires mayfacilitate removal. In other embodiments, other retrieval devices and/ormethods may be used to remove the device 205, 405 from the vagina.

Thus, the present invention as shown in the device embodiments describedherein allows for highly effective, near continuous relief fromdysmenorrhea that is not visible to the casual onlooker. When usedduring menses as an alternative to tampons, sanitary napkins, ormenstrual cups, the present invention allows for longer periods of use,reusability, and avoidance of potential medical risks such as ToxicShock Syndrome. When used as a barrier birth control method, the presentinvention limits or avoids the need for medical office fittings fordevice sizing and simpler and more hygienic use. For the various usesdescribed herein, the device and insertion method of the presentinvention provides for ease of insertion and correct placement for thedesired therapeutic effect.

The present invention has been described in particular detail withrespect to one possible embodiment. Those of skill in the art willappreciate that the invention may be practiced in other embodiments.Finally, it should be noted that the language used in the specificationhas been principally selected for readability and instructionalpurposes, and may not have been selected to delineate or circumscribethe inventive subject matter. Accordingly, the disclosure of the presentinvention is intended to be illustrative, but not limiting, of the scopeof the invention, which is set forth in the following claims.

1. A method for providing therapeutic heat to a cervical region,comprising: inserting an intra-vaginal device into the cervical region;providing the therapeutic heat to the device; wherein the therapeuticheat is transferred from the device to the cervical region.
 2. Themethod of claim 1, wherein the therapeutic heat provides foramelioration of discomfort of the cervical region.
 3. The method ofclaim 1, wherein the therapeutic heat is between 97.0 and 120.0 degreesFahrenheit.
 4. The method of claim 1, wherein the therapeutic heat isbetween 99.00 and 106.00 degrees Fahrenheit.
 5. The method of claim 1,wherein the therapeutic heat is between 100.00 and 104.00 degreesFahrenheit.
 6. The method of claim 1, wherein the therapeutic heat isadjustable by a temperature control associated with the device.
 7. Themethod of claim 1, wherein the cervical region comprises tissuesimmediately surrounding a cervix uteri.
 8. An apparatus for providingtherapeutic heat to a cervical region, the apparatus comprising: anintra-vaginal device for placement into the cervical region; a heatsource for providing the therapeutic heat to the intra-vaginal device;and wherein the therapeutic heat is transferred to the cervical regionfrom the intra-vaginal device.
 9. The apparatus of claim 8, wherein thetherapeutic heat provides for amelioration of discomfort of the cervicalregion.
 10. The apparatus of claim 8, wherein the therapeutic heat isbetween 97.0 and 120.0 degrees Fahrenheit.
 11. The apparatus of claim 8,wherein the therapeutic heat is between 99.00 and 106.00 degreesFahrenheit.
 12. The apparatus of claim 8, wherein the therapeutic heatis between 100.00 and 104.00 degrees Fahrenheit.
 13. The apparatus ofclaim 8, further comprising: a temperature control associated with theheat source for adjusting the therapeutic heat.
 14. The apparatus ofclaim 8, wherein the device approximates the shape of a cervix uteri.15. The apparatus of claim 8, wherein the heat source comprises a heattransfer means selected from the group consisting of electric, fluidflow, exothermic chemical reaction, passive, or thermonuclear.
 16. Theapparatus of claim 8, wherein the cervical region comprises tissuesimmediately surrounding a cervix uteri.
 17. The apparatus of claim 8,wherein the device is shaped as a hollow inverted conical frustum. 18.An intra-vaginal device for placement adjacent to a cervix uteri, thedevice comprising: an approximately circular ring base; a plurality offlaps attached to the circumference of the ring base at a first end ofthe flaps, the flaps adjacent to each other and collectivelyapproximating a hollow inverted frustum with an internal diameter sizedto approximate the cervix uteri, wherein a second end of the flapsapproximates a top base of the hollow inverted frustum; and wherein thedevice is fabricated from a material that allows the plurality of flapsto overlap so as to decrease an overall diameter of the device forinsertion.
 19. The device of claim 18, wherein the material comprises ahypoallergenic, elastomeric material.
 20. The device of claim 18,wherein the ring base is hollow.
 21. The device of claim 20, whereinwhen the device is in place, the ring base hollow defines an aperturesubstantially in alignment with the os of the cervix uteri.
 22. Thedevice of claim 18, wherein the ring base is solid, and furthercomprising: webbing between each of the flaps such that the flapscollectively form a continuous structure.
 23. The device of claim 18,wherein the device is configured for delivering therapy to the cervicalregion.
 24. The device of claim 23, wherein the therapy is selected fromthe group consisting of: heat therapy, chemical therapy, hormonetherapy, contraception, and retention of menstrual fluid.
 25. The deviceof claim 23, wherein the therapy comprises at least two selected fromthe group consisting of: heat therapy, chemical therapy, hormonetherapy, contraception, and retention of menstrual fluid.
 26. Anintra-vaginal device for placement adjacent to a cervix uteri, thedevice comprising: an approximately circular ring base; a plurality offlaps attached to the circumference of the ring base at a first end ofthe flaps, the flaps adjacent to each other and collectivelyapproximating an inverted bowl with an internal diameter sized toapproximate the cervix uteri, wherein a second end of the flapsapproximates a top base of the hollow inverted frustum; and wherein thedevice is fabricated from a material that allows the plurality of flapsto overlap so as to decrease an overall diameter of the device forinsertion.
 27. An apparatus for placement of an intra-vaginal deviceadjacent to a cervix uteri, comprising: a cylindrical outer tubecomprising an insertion end, a body, and a grip end; a plungercomprising a device end, a body, and a force receiving end, wherein theplunger is slideably received inside the cylindrical outer tube suchthat a force applied on the force receiving end of the plunger expelsthe intra-vaginal device from the cylindrical outer tube at theinsertion end; and wherein the device end comprises an approximatelyhemispherical convex tip sized to nestle inside an approximatelycircular ring base portion of the intra-vaginal device.
 28. Theapparatus of 27, wherein the hemispherical tip allows for transfer ofthe force from the plunger to the device such that the device pivotsinto alignment with the cervix uteri.
 29. The apparatus of claim 27,wherein the device comprises: the approximately circular ring baseportion; a plurality of flaps attached to the circumference of the ringbase portion at a first end of the flaps, the flaps adjacent to eachother and collectively approximating a hollow inverted frustum with aninternal diameter sized to approximate the cervix uteri, wherein asecond end of the flaps approximates a top base of the hollow invertedfrustum; and wherein the device is fabricated from a material thatallows the plurality of flaps to overlap so as to decrease an overalldiameter of the device for insertion.
 30. The apparatus of claim 27,wherein when the device is in place, the ring base hollow defines anaperture substantially in alignment with the os of the cervix uteri. 31.The apparatus of claim 27, wherein the device is configured fordelivering therapy to a region surrounding the cervix uteri.
 32. Theapparatus of claim 27, wherein the apparatus is introduced into avaginal canal with the intra-vaginal device positioned in a constrainedconfiguration inside the cylindrical outer tube at the insertion endproximate the device end of the plunger.
 33. The apparatus of claim 32,wherein applying a force to the force receiving end of the plungercauses the intra-vaginal device to be expelled from the cylindricalouter tube at the insertion end and to change into an expandedconfiguration; and wherein a first portion of the device, once in theexpanded configuration, contacts a first fornix, causing the force to betransferred along the hemispherical convex tip such that a secondportion of the device contacts a second fornix.
 34. A method of using anapparatus for placement of an intra-vaginal device adjacent to thecervix uteri, the apparatus comprising a cylindrical outer tubecomprising an insertion end, a body, and a grip end, and a plungercomprising a device end, a body, and a force receiving end, and whereinthe plunger is slideably received inside the cylindrical outer tube, themethod comprising: introducing the apparatus, with the intra-vaginaldevice positioned in a constrained configuration inside the cylindricalouter tube at the insertion end proximate the device end of the plunger,into the vaginal opening positioned for placement of the intra-vaginaldevice adjacent to the cervix uteri; applying a force to the forcereceiving end of the plunger, causing the intra-vaginal device to beexpelled from the cylindrical outer tube at the insertion end and tochange into an expanded configuration; and wherein a first portion ofthe device, once in the expanded configuration, contacts a first fornix,causing the force to be transferred along the hemispherical convex tipsuch that a second portion of the device contacts a second fornix. 35.The method of claim 34, wherein the device end comprises anapproximately hemispherical convex tip sized to nestle inside anapproximately circular ring base portion of the intra-vaginal device.36. The method of claim 34, wherein the device comprises: anapproximately circular ring base; a plurality of flaps attached to thecircumference of the ring base at a first end of the flaps, the flapsadjacent to each other and collectively approximating a hollow invertedfrustum with an internal diameter sized to approximate the cervix uteri,wherein a second end of the flaps approximates a top base of the hollowinverted frustum; and wherein the device is fabricated from a materialthat allows the plurality of flaps to overlap so as to decrease anoverall diameter of the device for insertion.
 37. The method of claim34, wherein the device is configured for delivering therapy to thecervical region.